Principais Responsabilidades
Selection of excipients and manufacturing processes to prepare prototype formulations which meet drug product requirements;
Design and execute pre-formulation studies to support Product Development work;
Design and execute formulation screening experiments using different types of components, technologies and using different statistical software;
Design and execute formulation development studies within an R&D environment;
Draft protocols and production batch records;
Conduct technical risk assessment to identify risks and mitigation opportunities to enable successful development and scale-up to GMP Manufacturing Environment;
Conduct formulation and process scale up activities to GMP environment;
Document and report result of all experiments in a manner consistent with department practices and governing policies, as applicable;
Generate, collect, interpret data sets and author reports and presentations, to share product knowledge and project progress with clients;
Oversee GMP production and provide support as required;
Provide scientific support in all aspects of formulation and drug product development;
Work closely with Clients, Partners or CRO's in developing formulations and processes;
Present data and actively participate in discussions on development activities, experimental design, etc;
Participate in project updates for client's technical calls;
Author and review protocols and development reports which will support Drug Product Dossier submission for global filings;
Identify and troubleshoot process challenges during GMP batch execution and propose strategies for formulation and process improvements;
Write SOPs, protocols and reports as required;
Ensure that all work is performed within established key workflows and/or regulations as described by SOPs, corporate policies and external regulatory guidance, as well as in compliance with the applicable cGMPs and GLPs;
Give technical support to the Business Development team as required;
Represent the Formulation Development function in cross-functional project teams and during client project meetings as required;
Perform other related duties as required.
Requisitos
M.Sc. or Ph.D. in relevant scientific discipline as Pharmaceutical, Chemical, Engineering or other related;
Experience at least 3-5 years real world development of pharmaceutical dosage forms experience (maybe as part of postgraduate education) in formulation and process development and scale-up and/or clinical manufacture;
Familiarity with pharmaceutical industrial framework;
Fluency in English (oral and written);
Good computer skills (Microsoft Word, Excel and statistics-based programs);
Strong time management and organization skills;
Communication skills to develop good working relationships and to work effectively in a team environment;
Strong analytical and problem-solving skills;
Close attention to details and high commitment to quality;
Be proactive and critical.
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